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If your company is developing a complex point-of-care (POC) instrument, and is planning to hire a contract engineering, manufacturing partner to design and manufacture the instrument itself, at what point should you engage the partner?

Point-of-care instruments can require intricate disposable cartridges, which contain growing technical complexities and multiple reagents to process only one patient sample at a time. Given this complexity, changes in the disposable design can be a precursor to major architecture overhauls in the instrument that processes the cartridges. Such changes to the medical device design can result in costly re-designs and lost time if not approached with forethought and planning from the beginning. That's why it's important to integrate a contract manufacturing and engineering partner from the start.

To clear this hurdle, first evaluate and demonstrate feasibility - before beginning the hardware and software development of the instrument. Because cartridge and instrument design are so interrelated, it is also critical to involve a contract manufacturer early in the process.

Partnering early in the project allows both parties to prioritize features and functions at the concept stage in order to meet end-user price and performance requirements. Using a well-defined proven process for medical instrument engineering, design and manufacturing ensures that the cartridge and instrument work perfectly together, which helps avoid costly changes and a delay to market.